In many oral medication regimes, patients or experimental subjects are required to take multiple oral medications and/or doses at specified intervals during the day. There are several reasons why such patients do not comply with their regimens, but a large percentage (1) simply forget, (2) cannot get prescriptions filled or delivered, or (3) do not like the side effects. It is common for such patients to forget to take the medications at the proper time or even to take multiple doses because of difficulties in remembering what they have already taken. The risks of not complying with the prescribed regimens and suffering the symptoms of under-dosing or over-dosing are well documented. The costs of treating the resulting medical problems have been estimated at over $100 billion per year in the US alone.
A large factor in the lack of compliance is inconvenience. While bottles are ideal as a delivery system for tablets or capsules from the pharmacy to the patient, they are not conducive to patient compliance. The inconvenience for a given patient increases dramatically with: (1) the number of medications in separate containers that the patient has to take, (2) the number of daily repetitions of each medication, (3) the complexity of the rules governing the how and when to take the medications, especially if some have to be taken during normal sleeping times, or with food, or on an empty stomach, and (4) under-dosing or the side-effects that arise out of the slight overdosing because the medications can only be roughly titrated to the specific patient's metabolism (in order to balance efficacy and side-effects). This is because medications are available only in certain dosages in relatively large increments.
Products and services have been introduced to the market in an attempt to improve compliance. There are online services that offer free or fee-based automated reminders on a daily or other user-selected basis, via email or cell phone, to remind patients to take their medicines (such as services offered by Freeminder.com and Iping.com). Over time, some patients begin to ignore the reminders, while others dislike the ‘automated’ nature of the reminders and prefer a ‘human touch’.
Some existing solutions also provide a multi-dose package containing all the medications to be taken by a particular patient at a particular time of day. These take the form of cups containing pills and capsules such as in the MD2 product from E-Pill.com, and rely on caregivers to fill the containers with the appropriate medications, leaving open the possibility of errors, especially for complex regimens. In some cases, reminders may be programmed into a device by the patient or caregiver. Some solutions automate the process of dispensing the appropriate pills and capsules, such as a system described in U.S. Pat. No. 5,839,257, and rely on a nurse or other licensed practitioner to administer the multi-dose to the patient and record the compliance event, typically in a hospital or managed facility setting. Due to cost and other factors, these may not be suited for patient self-administration. Yet other solutions use specially constructed blister packaging incorporating specialized electronics to detect compliance events. Some even provide remote dispensing of medications of different dosage strengths. These solutions are expensive since they rely on proprietary packaging and do not provide the convenience of a single package. There are also combinations of multiple drugs into a single pill or capsule, referred to as ‘cocktail’ therapy, but due to size limitations, these are usually for a single disease.
More recently, electronics-enabled blister packs have become available—these provide multiple medications and automated compliance recording, but are either expensive or have size limitations and thus may not be able to handle complex regimens. Other solutions such as a ‘Smart Tray’ with embedded RFID enabled medication containers, record which medication vials are removed from the tray and the time of removal; the data are transmitted to an online database as compliance events. In yet another solution, each medication vial is fitted with an RFID enabled detector that records the opening of the vial as a compliance event. The drawback in recording the opening of each container is that the patient still has to open each individual vial and manually assemble the requisite pills or capsules before taking them. In addition, the amount of data recorded is dependent on the number of containers rather that just the act of opening a single package. In many of the above cases, a special device or computer interface hardware and software must also be provided to patients, posing limits on scalability and speed of adoption.
In general, the above solutions address specific parts of the overall problem and have thus far failed to make a significant impact on patient compliance. The system described hereafter builds on some of these existing solutions, or parts thereof, to provide a more comprehensive solution.